Project Summary Abstract The Toxicology Forum provides a unique venue for advancing US FDA's regulatory science agenda and thereby improving public health. The Toxicology Forum conducts transparent dialogues among various segments of society concerned with problems in toxicology. Each scientific session represents a carefully balanced approach to the designated topic with all sides of an issue presented for each topic. The unique, non- adversarial atmosphere of Toxicology Forum meetings results in frank and open discussions that do not need to arrive at consensus but foster a common understanding of the issue. Each scientific session of the Toxicology Forum provides an opportunity to develop a common understanding of the latest scientific data, the interpretation of the data and the policy implications of the findings. Programs in the past 15 years have emphasized new scientific tools (genomics, proteomics, metabolomics) and how these tools allow better decisions on safety of products regulated by the US FDA. There has been increased emphasis on challenging the traditional bioassays in terms of human relevance and discussion of alternative assays for product safety assessments have been the subject of multiple discussions which has help to develop a common understanding of the proper interpretation of this and other preclinical toxicology studies. These programs support the goals outlined in US FDA's Strategic plan for Regulatory Science and the advancement of public health. US FDA relevant elements of the Toxicology Forum that have been expanded and formalized in recent years include increasing opportunities for leading younger academic scientists to participate in Forum discussions through Travel Fellowships for young academic faculty. Another important change began in the late 1990s with the establishment of annual European meetings in Brussels, the seat of the European Union. This international scope supports US FDA's globalization efforts to strengthen national regulatory systems. While the specific issues and regulatory mechanisms may vary depending on the continent and country involved, the Toxicology Forum meetings continues to be a valid and productive way to explore and discuss issues with government, industry, academia, and consumer groups.